A randomised comparison of two different methods of intrabronchial lignocaine delivery during flexible bronchoscopy
| ISRCTN | ISRCTN77331907 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77331907 |
| Protocol serial number | N/A |
| Sponsor | Lancashire Teaching Hospitals NHS Trust (UK) |
| Funder | Lancashire Teaching Hospitals NHS Trust (UK) - Research and Development Directorate (ref: JDM/MJ) |
- Submission date
- 29/01/2010
- Registration date
- 16/03/2010
- Last edited
- 03/04/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michelle MacDougall
Scientific
Scientific
1 Werneth Close
Preston
PR19TS
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled open label prospective single centre study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised, controlled, open label, prospective, single centre study to investigate the use of the ENK device when compared to the standard syringe administration of 2% lignocaine solution when performing diagnostic flexible bronchoscopy |
| Study objectives | There is no difference in efficacy of local anaesthetic administration between standard "spray as you go" technique or the use of the ENK device during flexible bronchoscopy. |
| Ethics approval(s) | Preston, Chorley and South Ribble Local Research Ethics Committee approved on the 22nd March 2004 (ref: 2003.10.ix) |
| Health condition(s) or problem(s) studied | Local anaesthetic delivery in bronchoscopy |
| Intervention | Administration of local anaesthetic via either the standard "spray as you go" technique or nebulised through the bronchoscope via the ENK device (which has been used to assist in awake intubations previously. The same local anaesthesic agent is used for all participants with the volume used titrated according to the clinician's assessment of requirement. All patients complete a questionnaire greater than 24 hours following the procedure (and return it in a pre-addressed and stamped envelope). No additional follow up is required. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Visual analoque scale assessments by doctor, nurse and patient regarding ease of procedure, extent of coughing and patient tolerance. Doctor and nurse questionnaires completed immediately following the procedure. Patient questionnaires completed more than 24 hours later (to ensure there is no lasting effect of any sedative medication used). |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 27/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | All adult patients (either sex) attending Royal Preston Hospital for diagnostic flexible bronchoscopy |
| Key exclusion criteria | Patients undergoing interventional procedures (e.g. tracheobronchial stenting, transbronchial biopsy or intrluminal palliative therapies) |
| Date of first enrolment | 05/05/2004 |
| Date of final enrolment | 27/09/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
1 Werneth Close
Preston
PR19TS
United Kingdom
PR19TS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
